Health TrialsbyHealthPanel

Capsule Microbiota Transplant Therapy for Hidradenitis Suppurativa

ConditionHidradenitis Suppurativa
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Minnesota

About this trial

HS is relatively common in the United States with a prevalence of 0.1-1.0%. 1 HS has a dramatic impact on quality of life, significantly more so than other chronic skin diseases, such as psoriasis or atopic dermatitis (AD). HS also has a large economic impact, due to frequent emergency department and inpatient care utilization, and re-hospitalization rates similar to congestive heart failure. Unfortunately, few treatment options are effective. There are currently three FDA-approved treatments for HS, including adalimumab, secukinumab, and bimekizumab, each with only 40- 60% respond to treatment and over 50% lose response within one year . The overarching goal of this pilot study is to investigate the central hypothesis that oral microbiota transplant therapy(MTT) alters the gut microbiome in patients with Hidradenitis Suppurativa (HS), influencing cutaneous microbiota via systemically absorbed gut-derived metabolites.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Able and willing to provide informed consent

English speaking

Age >= 18years of age

Diagnosis of hidradenitis suppurativa by a dermatologist

Disqualifiers

Non-English speaking

Refusal or inability to provide informed consent

Planning on moving within 6 months from start of study

Allergy to neomycin or vancomycin

Trial design

Design model

Parallel

Treatments tested in this trial

  • Fecal Microbiota - lyophilized

    Drug

    Patients receive 2 capsules daily for one week followed by one capsule daily for 2 weeks. MTT capsules are derived from a single donor per patient.

  • Placebo drug

    Drug

    The placebo consists of a mixture of trehalose and crystalline methylcellulose (Avicel) in 6:1 (w/w) ratio that is packaged in size 0 swedish orange capsules, which are then double encapsulated in size 00 natural colored capsules to make them visibly indistinguishable from encapsulated active product.

Treatment groups

16 Participants
are divided into 2 treatment groups
Group A: MMT groupExperimental treatment 1 intervention
Group B: Placebo groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Percent donor engraftment

Percent donor engraftment based on Bayesian, community-wide, culture-independent microbial source tracking

Time frame
Baseline, 6 weeks, 12 weeks

Secondary outcomes

1

Skin toxonomic relative abundances and diversity indices

Change in skin taxonomic relative abundances and diversity indices (alpha and beta diversity) at 6 and 12 weeks compared to baseline (t- test and regression-analysis evaluating change overtime for two and three time points)

Time frame
6 weeks, 12 weeks
2

Stool toxonomic relative abundances and diversity indices

Change in stool taxonomic relative abundances and diversity indices (alpha and beta diversity) at 6 and 12 weeks compared to baseline (t- test and regression-analysis evaluating change overtime for two and three time points)

Time frame
6 weeks, 12 weeks
3

Stool small chain fatty acids

Change in stool small chain fatty acids (butyrate, acetate and propionate) at 12 weeks compared to baseline

Time frame
12 weeks
4

Serum small chain fatty acids

Change in serum small chain fatty acids (butyrate, acetate and propionate) at 12 weeks compared to baseline

Time frame
12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Minnesota

Lead sponsor

Source ClinicalTrials.gov
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